The Ministry of Food and Drug Safety said it would put off enhancing insulin delivery rules by six months because there was insufficient insulin to go around.
On Thursday, the MFDS said it would extend the “guidance period” for insulin products by six months until Jan. 17, 2023, before applying reinforced rules on the distribution temperature management of biological products.
The extended guidance period will help supply insulin to pharmacies stably and minimize the inconvenience of diabetic patients, the MFDS said.
On Jan. 17, the MFDS had given a six-month guidance period until July 17 regarding the enhancement of temperature control for biological drugs.
Under the new rules, drug distributors must install automatic temperature recorders in transport containers or vehicles for biological products, regularly inspect automatic temperature recorders, and verify the adequacy of transport facilities.
However, drug distributors argued that such rules would drive up the costs of insulin delivery and weigh on the industry.
In Korea, a small number of distributors receive insulin from multinational pharmaceutical firms. Then, the distributors supply insulin to many small- and medium-sized distributors.
Industry officials worried that low margins for secondary distributors could give up supplying insulin to pharmacies, and diabetic patients could fail to get insulin.
Indeed, some diabetic patients recently started searching for inventory after failing to get insulin.
To address the problem, the MFDS on Tuesday met with patient groups, insulin distributors, the Korean Pharmaceutical Association (KPA), and drugmakers and discussed the extension of the guidance period and an efficient supply of insulin to pharmacies.
After the meeting, the government concluded that the guidance period needed a six-month extension. Also, the government said it would work closely with the industry to supply insulin smoothly.
The MFDS said it would build a system to share information on insulin wholesalers and enhance monitoring of the insulin supply.
Under the new system, the government will receive insulin wholesalers’ information such as the name, region, and contact number) and relay it to the KPA. Then, the KPA will spread the information to pharmacies to support a smooth insulin supply.
During the guidance period, the MFDS will work with the Korea Pharmaceutical Distribution Association to monitor changes in the number of insulin deliveries and whether or not distributors were equipped with transport facilities.
However, the government noted that it would not exclude insulin from the upcoming enhanced temperature control rules for biological drugs. Industry officials are paying attention to how the latest measures will help relieve the shortage of insulin supply.